Sr Specialist, Quality

ONSITE ROLE IN EXTON, PA

 

Who We Are

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

This position is responsible for all stages of receiving customer complaint, interacts with customer for additional information, acting as a liaison with plant QA, TCS, Sales, Order Fulfilment, Data Governance, and other areas necessary to satisfy customer’s expectations. It leads and manages the customer complaint process to ensure that the system is in place and procedure is being followed. Complies customer complaint specific data as needed to support customer’s review meeting in general.

 

Essential Duties and Responsibilities:

• Provide support to Quality group ensuring consistent application of procedures in place
• Manage key projects/initiatives related to customer complaints and ensures that progress is within expected guidelines and timelines.
• As the point of quality contact when receiving customer complaints, performs a variety of duties such as assembling all information (customer and West), coordinating and managing multidisciplinary technical review teams (Lab, TCS, QS, etc) when necessary for critical complaints
• Aid initial receipt, review, trending and impact assessments for customer complaint issues
• Receive and proper handling of customer complaint and compliant samples in the West System
• Enter customer complaints in SAP.
• Coordinates and manages day-to-day operations and communications with customer and internal departments/plants to ensure all information is available on time to perform customer complaint investigation
• Ensure all customer information necessary to initiate the investigation is received and recorded accordingly
• Facilitate communication between West and customer on complaint critical issues and aid the plant in preparation for the meeting and ensure expectation is aligned
• Coordinate customer credit for complaints involving return and credit disposition
• Work with QA sites and Exton Lab personnel to meet target customer satisfaction goals on investigation response time
• Identify opportunities for improvement on complaint process in general
• Review complaint data, analyzes results and recommends changes based upon findings. Prepare customer specific complaint data and trend as requested
• Prepare report by collecting, analyzing and summarizing data, making recommend
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

 

Basic Qualifications: 

• Education: Bachelor’s or equivalent work experience
• Experience: Minimum 5 years of experience in Quality and/or customer complaint system

 

Preferred Knowledge, Skills and Abilities:

• Attention for detail and deadline driven
• Strong verbal and written communication skills
• Working familiarity with root cause investigation tools
• Ability to work independently, multi-task and thrive in fast-paced environment
• A sense of urgency/initiative
• Demonstrate team building and problem-solving skills
• Knowledge of cGMP requirements and ISO standards
• Ability to effectively prioritize and escalate issues
• Experience with customer interface and meeting customer expectations

 

Travel Requirements:

• Up to 5% travel, minimal

 

Physical & Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the tim